DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of group I, species A, claims 21-27 in the reply filed on 11/25/2025 is acknowledged.
Claims 28-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group II and species B, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/25/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/9/2023 was received and placed in the record on file. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Currently no claim limitations are being interpreted as invoking 35 USC 112(f).
Double Patenting
Statutory DP
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 23 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 8 of prior U.S. Patent No. 11,877,847. This is a statutory double patenting rejection.
Specifically, every limitation of claim 23 is recited in claim 8 (dependent on Claim 7) of US 11,877,847 as outlined below:
Instant Claim 23
Claim 8 of US 11,877,847 re-organized for comparaison
A biosensor apparatus, comprising:
a semiconductor biosensor device, comprising:
a surface section comprising processing circuitry and a first contact pad, the processing circuitry comprising:
an analog-to-digital converter (ADC);
a processing device operably connected to the ADC; and
a wireless communication device operably connected to the processing device and to an antenna; and
an implantable section for implanting in a user's skin, the implantable section comprising:
a bending detector; and
a sensing region comprising: a plurality of biomarker sensor arrays, each biomarker sensor array comprising a plurality of biomarker sensors operable to detect a biomarker;
a control biomarker sensor array comprising a plurality of biomarker-insensitive sensors;
a biofouling detector; and
a temperature sensor,
wherein the sensing region and the bending detector are operably connected to the processing circuitry; and
a cover operable to attach to the semiconductor biosensor device, the cover comprising: a second contact pad electrically connected to the first contact pad; and the antenna.
(Claim 7): A biosensor apparatus, comprising:
a semiconductor biosensor device, comprising:
a surface section comprising processing circuitry and a first contact pad, (from claim 8) wherein the processing circuitry comprises:
an analog-to-digital converter (ADC);
a processing device operably connected to the ADC; and
a wireless communication device operably connected to the processing device and to an antenna; and
an implantable section for implanting in a user's skin, the implantable section comprising:
a bending detector; and
a sensing region comprising: a plurality of biomarker sensor arrays, each biomarker sensor array comprising a plurality of biomarker sensors operable to detect a biomarker;
a control biomarker sensor array comprising a plurality of biomarker-insensitive sensors;
a biofouling detector; and
a temperature sensor,
wherein the sensing region and the bending detector are operably connected to the processing circuitry; and
a cover operable to attach to the semiconductor biosensor device, the cover comprising: a second contact pad electrically connected to the first contact pad; and the antenna.
Non-Statutory DP
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21, 22 and 24-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and 10-15, of U.S. Patent No. 11,877,847 in view of Kamath (US 2010/0179409 A1).
Regarding claim 21; Claim 7 of US 11,877,847 discloses: A biosensor apparatus, comprising:
a semiconductor biosensor device, comprising:
a surface section comprising processing circuitry and a first contact pad (column 21, lines 5-7);
an implantable section for implanting in a user's skin, the implantable section comprising (column 21, lines 8-9):
a bending detector (column 21, line 10); and
a sensing region comprising (column 21, line 11):
a plurality of biomarker sensor arrays, each biomarker sensor array comprising a plurality of biomarker sensors operable to detect a biomarker (column 21, lines 12-15);
a control biomarker sensor array comprising a plurality of biomarker-insensitive sensors (column 21, lines 16-17);
a biofouling detector (column 21, line 18); and
a temperature sensor (column 21, line 19),
wherein the sensing region and the bending detector are operably connected to the processing circuitry (column 21, line 20-23); and
a cover operable to attach to the semiconductor biosensor device, the cover comprising: a second contact pad electrically connected to the first contact pad; and the antenna (column 21, lines 24-27).
Claim 7 of US 11,887,847 does not explicitly recite the processing circuitry comprises: an analog-to-digital converter (ADC), a processing device operably connected to the ADC, and a wireless communication device operably connected to the processing device and to an antenna.
Kamath teaches a similar biosensor for use on the body having processing circuitry wherein the processing circuitry comprises: an analog-to-digital converter (ADC) (element 21), a processing device operably connected to the ADC (element 22), and a wireless communication device (element 27) operably connected to the processing device (element 22) and to an antenna (wherein examiner notes that RF transceivers require an antenna in the form of a coil in order to receives/transmit signals) (paragraphs [0196]-[0201]; figure 2).
Regarding claim 21, 22 and 24-27; it would have been obvious to one of ordinary skill in the art at the time of filing to utilize known processing circuitry in US 11,887,847 biosensor device including an ADC, a processing device, and a wireless communication device with an antenna as taught by Kamath as simple substitution of one known element for another to obtain a predictable result (replacing US 11,887,847 with Kamath’s processing circuitry to provide US 11,887,847 having an ADC, a processing device and a wireless communication device with an antenna).
Further regarding claim 22; claim 10 of US 11,887,847 discloses the first contact pad is electrically connected to a first printed circuit board and to the second contact pad on a second printed circuit board that is in the cover.
Further regarding claim 24; claim 12 of US 11,887,847 recites a comparator circuit, wherein the selected signal is input into a first input of the comparator circuit and a signal from a biomarker- insensitive sensor in the control biomarker sensor array is input into a second input of the comparator circuit and the output signal output from the comparator circuit is used for pH calibration.
Further regarding claim 25; claim 14 of US 11,887,847 recites the biofouling detector comprises two interdigitated electrodes operably connected to impedance sensing circuitry and an output signal output from the impedance sensing circuitry is used for calibration.
Further regarding claim 26; claims 11 and 13 of US 11,887,847 recites the bending detector comprises a cantilever-beam resistor that is operably connected to resistance sensing circuitry and an output signal output from the resistance sensing circuitry is used for calibration.
Further regarding claim 27; claim 15 of US 11,887,847 recites the sensing region further comprises a reference electrode.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 21-23, 25 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Buck (US 2012/0088993 A1) in view of Kamath (US 2010/00179409 A1), Bhavaraju (US 2014/0005509 A1) and Wolpert (US 8,287,454 B2).
Regarding claim 21-23, 25 and 27; Buck discloses a biosensor apparatus (paragraph [0040], comprising:
a semiconductor biosensor device (element 20), comprising:
a surface section (figures 1a, 1b) comprising processing circuitry (paragraph [0040]) and a first contact pad (contact portion element 22); and
an implantable section (element 24) for implanting in a user's skin (paragraphs [0034]), the implantable section comprising:
a sensing region (element 24) comprising: a plurality of biomarker sensor arrays (elements 40, 42, and 44) each biomarker sensor array comprising a plurality of biomarker sensors operable to detect a biomarker (paragraphs [0031]-[0036]; figures 1a-1b).
However, Buck does not explicitly disclose the processing circuitry comprises an analog-to-digital converter (ADC), a processing device operably connected to the ADC, and a wireless communication device operably connected to the processing device and to an antenna; or that the implantable section includes a bending detector, a control biomarker sensor array comprising a plurality of biomarker-insensitive sensors, or a temperature detector.
Kamath teaches a similar biosensor for use in the body having processing circuitry wherein the processing circuitry comprises: an analog-to-digital converter (ADC) (element 21), a processing device operably connected to the ADC (element 22), and a wireless communication device (element 27) operably connected to the processing device (element 22) and to an antenna (wherein examiner notes that RF transceivers require an antenna in the form of a coil in order to receives/transmit signals) (paragraphs [0196]-[0201]; figure 2). Kamath further discloses the biosensor includes an implantable section includes a signal artifact detector (element 29 and 84; figures 2 and 8) which can include a bending detector (strain gauge element 29d); a control biomarker sensor array comprising a plurality of biomarker-insensitive sensors (elements 29a, 29b) and a temperature detector (element 39c) which are used to detect and indicate the signal reliability of the measured biomarkers (paragraphs [0294], [0368], [0470]).
Regarding claim 21-23, 25 and 27; Bucks discloses a biosensor as described above. Kamath teaches known processing circuitry for use in a biosensor. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to utilize known processing circuitry in Buck’s biosensor device including an ADC, a processing device, and a wireless communication device with an antenna as taught by Kamath as simple substitution of one known element for another to obtain a predictable result (replacing Buck’s processing circuitry with Kamath’s processing circuitry to provide Buck/Kamath combination having Buck biosensor structure with Kamath’s ADC, a processing device and a wireless communication device with an antenna for processing the measured signals). Furthermore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Buck’s biosensor to modify the implantable section to include a bending sensor, a control biomarker sensor array comprising a plurality of biomarker-insensitive sensors, and a temperature sensor as taught by Kamath in order to provide a signal artifact detector operably connected to the processing circuitry to detect and indicate a signal reliability of the measured biomarkers (paragraphs [0294],[0368] and [0470])..
Further regarding claims 21-23, 25 and 27; the Buck/Kamath combination as described above does not explicitly disclose the implantable section includes a biofouling detector.
Bhavaraju teaches a continuous analyte sensor similar to Buck and Kamath wherein the continuous analyte sensor further provides for an impedance measurement between two subcutaneous electrodes used to identify a physiological condition or sensor failure such that the impedance measurements at various locations in the sensor area over time provide information on a biofouling condition in the sensor area (paragraphs [0195], [0229]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to further modify the Buck/Kamath combination to provide impedance sensors and electrodes on the implantable section as taught by Bhavaraju in order to measure impedance in the sensing region to detect a biofouling condition to determine the sensor status to provide more accurate glucose data.
Finally, regarding claims 21-23, 25 and 27; the Buck/Kamath/Bhavaraju combination as described above does not explicitly disclose a cover operable to attach to semiconductor biosensor device comprising a second contact pad electrically connected to the first contact pad; and an antenna.
Wolpert teaches an analyte monitoring device having an implantable section and a surface section wherein the surface section (base element 74) comprises a first contact pad (electrical contact element 80 of base element 74) and a cover (element 76) operable to attach to the biosensor device, the cover (element 76) comprising a second contact pad (electrical contact element 80 of cover element 76) electrically connected to the first contact pad (column 31, lines 19-36; figure 14) and the transmitter can be further coupled to an antenna in the housing (column 40, line 57 – column 41, line 4).
Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to further modify the Buck/Kamath/Bhavaraju combination to utilize a two piece cover and base housing configuration wherein the cover includes an antenna to connect to the transceiver wherein the base connects to the cover to form the housing via a first and second electrical contact pad as taught by Wolpert as use of a known technique (two part housing, implantable part and cover part having electronics) to improve similar devices (implantable analyte biosensors) to yield a predictable result (in this case the Buck/Kamath/Bhavaraju combination wherein the biosensor is connectable to a cover via first and second contact pads to form a housing and complete the sensor for monitoring a biomarker in the body).
Further regarding claim 22; Wolpert teaches the first contact pad is electrically connected to a first printed circuit board and the second contact pad is on a second printed circuit board in the cover (column 31, lines 19-36; figure 14). Therefore the Buck/Kamath/Bhavaraju/Wolpert combination as described above would also have the same configuration for electrically connecting the electronics in the base and cover section as taught by Wolpert.
Further regarding claim 23, Buck/Kamath/Bhavaraju/Wolpert combination is described above. Bhavaraju further discloses that select electrodes are activated in order to take the impedance measurement between the activated electrodes utilizing a processing/control module to identify and process the sensor condition. Therefore it would have been obvious to one of ordinary skill in the art at the time of filing that the Buck/Kamath/Bhavaraju/Wolpert combination includes a select circuit (the processing circuitry of Bhavaraju which can activate select electrodes for impedance measurement), operable to select a signal from a biomarker sensor in a biomarker sensor array in the plurality of biomarker sensor arrays (the activated selected electrodes used to obtain the impedance measurement).
Further regarding claim 25; Buck discloses the sensor configuration comprises interdigitated electrodes (working and counter electrodes; see figures 1a and 1b). The Buck/Kamath/Bhavaraju/Wolpert combination as described above further teaches the use of the electrodes to act as biofouling detectors connected to impedance sensing circuitry and an output signal from output the impedance sensing circuitry is used for calibration (Bhavaraju paragraphs [0190]-[0198]). Therefore it would have been obvious to one of ordinary skill in the art at the time of filing for the Buck/Kamath/Bhavaraju/Wolpert combination to utilize the interdigitated electrodes (Buck) and impedance sensing circuitry for calibration as taught by Bhavaraju.
Further regarding claim 27; Buck discloses the sensing region comprises a reference electrode (element 44). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing that the Buck/Kamath/Bhavaraju/Wolpert combination would also include a sensing electrode.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Buck in view of Kamath, Bhavaraju and Wolpert as applied to claim 21 above, and further in view of Goodall et al (US 2012/0209090).
Regarding claim 26; the Buck/Kamath/Bhavaraju/Wolpert combination is described in the rejection of claim 21 above. Kamath teaches the use of a bending detector and further discloses signal artifact detection bending detector can be monitored using known techniques placed on the sensor that detect pressure and/or stress on the circuit board and that a variety of MEMS can be utilized to measured pressure and/or stress within the sensor.
Goodall teaches an implantable sensor which can include a microcantilever that is configured to detect changes in cantilever bending in response to binding of one or more microorganisms to the surface of the sensor to detect artifact (paragraph [0122]).
Therefor it would have been obvious to one of ordinary skill in the art at the time of filing to substitute the Buck/Kamath/Bhavaraju/Wolpert combination signal artifact detection strain bending detector with a cantilever-beam resistor operably connected to resistance sensing circuitry and an output signal from the resistance sensing circuitry for calibration as taught by Goodall as simple substitution of one known element for another to yield a predictable result (in this case the Buck/Kamath/Bhavaraju/Wolpert combination using a cantilever/beam resistor instead of a strain sensor for detecting bending in the sensor chip).
Allowable Subject Matter
Claim 24 is not rejected over prior art of record.
Claim 24 is also is rejected over obviousness double patenting and could be allowed if amended to be in independent form and accompanied with an appropriate terminal disclaimer.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record as provided above to Buck, Kamath, Bhavaraju, Wolpert and Goodall does not disclose or make obvious the use of a comparator circuit and use of a selected biomarker sensor array and a signal from a biomarker-insensitive sensor in the control biomarker sensor array is input into a second input of the comparator circuit and the output signal output from the comparator circuit is used for pH calibration. Kamath teaches the use of a pH sensor for artifact detection, but none of the reference disclose the use of a comparator circuit along with the pH sensor for pH calibration.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 PM).
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/ADAM J EISEMAN/Primary Examiner, Art Unit 3791